Identity
- Trade Name
- NovaBone Dental Putty Cartridge Dispenser EUDAMED
- Device Name
- NovaBone Dental Putty Cartridge Dispenser EUDAMED
- Model / Reference
- EU3600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813909011486 EUDAMED
- Basic UDI-DI
- B-00813909011486 EUDAMED
- EMDN Code
- W02079003 DISPENSERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NovaBone Dental Putty Cartridge Dispenser by NovaBone Products, LLC — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813909011486 | Class I | Active |
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Manufacturer
- Manufacturer
- NovaBone Products, LLC
- EUDAMED SRN
- US-MF-000020624
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED aef48070-4f6a-44b5-b705-aa98a80d44c7 61 fields · synced Jul 17, 2026